Pace Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ultra Compression Screw System, which is indicated for the internal fixation and stabilization of arthrodesis, osteotomies, fractures, and foot/ankle nonunion.

The Ultra Compression Screw System introduces a patent-pending approach to mechanical compression and fixation, addressing longstanding challenges in achieving consistent bone apposition and stable union across a variety of anatomic sites. Its design delivers predictable compression, high pull-out strength, and consistent torque upon insertion as a new standard for forefoot, midfoot, and hindfoot applications.

“Surgeons know that reliable compression and ease of use determine success in foot and ankle reconstruction,” said Bill Rhoda, chief technology officer of Pace Surgical and general partner of Runway Healthcare. “The Ultra Compression Screw System was engineered in direct collaboration with surgeons to provide reproducible results and tactile feedback, and to restore anatomical constructs with purpose-built solutions. This clearance accelerates our plans to bring a differentiated solution to a growing procedural market.”

Pace’s Surgeon Design Team consists of some of the top minds in orthopedic reconstruction and foot and ankle surgery, globally from trauma, orthopedics, and podiatry, with James Kreig, M.D.; Samir Mehta, M.D.; Lew Schon, M.D.; Greg Guyton, M.D.; Nicholas Romansky, D.P.M.; and Steven Soondar, D.P.M.

With more than 1.5 million trauma and reconstruction foot and ankle procedures performed annually in the United States, the market for stable, easy-to-use fixation systems continues to expand as patient demand and surgeon efficiency pressures increase. Pace Surgical’s Ultra Compression Screw System delivers performance, simplicity, and versatility that appeals to both high-volume reconstructive surgeons and strategically positioned acquirers seeking a next-generation foot and ankle platform, company bigwigs said.

“As a surgeon, I know that much of how well a screw functions has to do with how accurately it has been inserted. In that regard, the handling characteristics are essential. How accurately can I place it, and can any surgeon do it as well?” stated Dr. Kreig, chief of Orthopaedic Trauma and Fracture Care at Rothman Orthopeadics, the professor of Orthopaedic Surgery at Thomas Jefferson University in Philadelphia, and head of Pace Surgical Surgeon Design team. “The ‘secret sauce’ of the Ultra Screw is a set of features that make it easier to start and provide for a more consistent torque required to insert. The predictable ‘just right’ insertional torque makes it easier to fully tighten the screw, without causing it to strip. I look forward to using the Ultra Screw in my practice.”

The Ultra Compression Screw System features a self-starting tip geometry and thread form that optimizes bone engagement, and reduced stripping, and allows for consistent torque through varying bone quality and densities.

The company plans a limited release of the Ultra Compression Screw System in select surgical centers, followed by a broader commercial rollout later next year of Pace’s full reconstruction offering, to include anatomical locking plates and screws.

Pace Surgical was founded to provide foot and ankle surgeons with anatomically appropriate surgical solutions to preserve anatomical constructs and quality of life for patients. Pace Surgical’s majority stockholder is Runway Healthcare LP, a medtech accelerator investment fund.

Runway Healthcare is an early-stage medical device venture studio focused on early-stage technology in the orthopedic, cardiovascular, and neurology sectors. Runway Healthcare finances and manages the product development process of its portfolio companies. Upon navigating a portfolio company through the regulatory process, Runway Healthcare will seek to transition the company’s ownership to larger multi-national healthcare companies for commercialization.